BPN-Biologics Resources

Researchers participating in the Blueprint Neurotherapeutics Network for Biologics receive grant funding (a UG3/UH3 award or U44 award if a small business) and no-cost access to biotherapeutic development consultants and contract research organizations (CROs).

Research Grants (UG3/UH3 or U44)

All projects that enter BPN-Biologics begin with a UG3 phase (or U44 Phase I) of up to two years, which should be used to complete all lead optimization activities (for Discovery-stage projects) or any additional preparatory activities needed to initiate IND-enabling studies (for Development-stage projects). This phase will also be used to engage the LDT in establishing a detailed research plan and go/no-go milestones for all subsequent work.

Projects can enter BPN-Biologics during the Discovery or Development stage and may seek support through phase I/first-in-human testing. Discovery involves biologic agent characterization and optimization in order to identify a suitable development candidate. During the Development stage, a candidate undergoes preclinical toxicology testing required for an IND and manufacturing, ultimately advancing to phase I/first-in-human testing. BPN-Biologics-supported Development activities include chemical manufacturing and controls (CMC), formulation development, toxicology studies, regulatory support, and phase I/first-in-human testing.

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BPN-Biologics Projects Phase diagram

Consultants

Each Lead Development Team receives support from BPN-Biologics consultants. Consultants are assigned to a project with considerations for the project team's individual needs and consultants' expertise.

CCS Associates, Inc.

Integrated Nonclinical Development Solutions, Inc.  

 

Contract Research Organizations

BPN researchers receive no-cost access to the network's Contract Research Organizations (CROs). LDTs plan and coordinate studies conducted by BPN CROs.

Collaborative Drug Discovery - data management

Duke University School of Medicine - clinical trials

PPD - clinical trials

SRI International - in vivo PK and Toxicology

 

Informational Resources

NIH Stem Cell Information

FDA Guidance Documents

FDA CBER Standard Operating Procedures and Policies (SOPPs)

Example Target Product Profiles: Target Product Profile (TPP)(pdf, 189 KB) 

Example Agent Profiles: 

                   Example Antibody Profile(pdf, 100 KB) 
                   Example Antisense Oligonucleotide Profile(pdf, 105 KB) 
                   Example Viral Gene Therapy Profile(pdf, 118 KB) 
                   Example Peptide or Protein Profile(pdf, 100 KB) 

 

 

BPN-Biologics Staff

Program Director
Dr. Ann-Marie Broome

Program Specialists
Dr. Julia Bachman

 

Project Managers

Dr. Chris Boshoff
Dr. Mario Skiadopoulos

Operations Coordinator
Ms. Natasha Davis

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Form Approved OMB# 0925-0648 Exp. Date 06/2024